Summary/Abstract Introduction: iCare will provide e?ective, home-based vision therapy through a motivating action-based video game that inspires adherence in patients as young as 4 years old. The proposed Phase IIB e?ort supports development of the commercial system; cloud-based tools for providers and patients; establishment of e?cacy and safety; and federal regulatory approval. Problem to be addressed: Convergence insu?ciency and amblyopia a?ect millions of children in the U.S. These disorders are associated with symptoms including headaches, blurred vision, eyestrain, di?culty concen- trating, and more. They can a?ect a child's school and social performance and have a detrimental impact on learning. It is known that vision therapy (prescribed neuromuscular and neurosensory exercises) can facilitate restoration of visual function. However, home-based interventions have historically been ine?ective due to low adherence rates. Long-Term Goal: Improved outcomes and access to care for children diagnosed with convergence insu?ciency and amblyopia. Phase II Results: In a successful Phase II program, a prototype vision therapy game was employed in a study involving children diagnosed with convergence insu?ciency (n=19) and amblyopia (n=5). A statistically- signi?cant improvement in vision was found in children who used iCare over 12 weeks of therapy. Adherence and technology acceptance results demonstrated improvement over a conventional computer-based intervention. Phase IIB Program Summary: The proposed Phase IIB e?ort yields a commercial iCare system supporting vision therapy for children as young as 4 years old. New development includes: game enhancements to incor- porate Phase II lessons learned; cloud services integration; a provider-facing web application for monitoring and guiding therapy; a patient-facing web application for software download and parental support; and a HIPAA- compliant data store. Pursuit of federal regulatory approval for the new device will include documentation of safety; creation of users guide and other labeling; and completion of actions supporting premarket noti?cation. A network of 10 vision therapy providers around the U.S. will participate in multi-site trials to demonstrate e?cacy for treatment of both convergence insu?ciency and amblyopia. Commercial Opportunity: There are approximately 4.7 million children in the U.S. ages with vision conditions that are treatable by iCare. Tremendous enthusiasm for the iCare product is demonstrated by included letters of support included from 10 di?erent vision therapy providers.